MAUDE Adverse Event Report: DEPUY SPINE INC ELLIPTICAL HANDLE; MISC ORTHO SURGICAL INSTR

Model Number	279702140
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the x25 driver was being used with a torque handle to perform the final tightening of the set screws, when the tip wouldn¿t engage properly.The threads on the tip of the driver were bent so a different x25 driver was used to complete this stage of the surgery.Concomitant device reported: unknown setscrew (part# unknown, lot# unknown, quantity unknown).This report is for one (1) elliptical handle.This is report 1 of 1 for (b)(4).
Event or Problem Description
This is report 1 of 2 for (b)(4).

• Brand Name: ELLIPTICAL HANDLE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11464296
• Report Number: 1526439-2021-00421
• Device Sequence Number: 4189186
• Product Code: LXH
• UDI-Device Identifier: 10705034198521
• UDI-Public: 10705034198521
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 279702140
• Device Catalogue Number: 279702140
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS; VIPER2 - INT X-25, SELF-RETAIN; UNKNOWN LOCKING/SET SCREWS; VIPER2 - INT X-25, SELF-RETAIN